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Johnson & Johnson
Johnson & Johnson
H1B vīzas sponsorsBiotehnoloģijaFarmaceitiskie produktiVeselības aprūpe
Johnson & Johnson ir globāls veselības aprūpes uzņēmums, kas darbojas farmācijas, medicīnas ierīču un patērētāju veselības jomā. Tā pētniecības un produktu izstrādes darbība ietver onkoloģijas, imunoloģijas, neirozinātnes, kā arī sirds un plaušu slimību zāles un terapijas, līdztekus MedTech risinājumiem sirds un asinsvadu aprūpei, ortopēdijai, ķirurģijai un redzes aprūpei. Uzņēmuma plašākā darbība ietver arī veselības un labklājības izglītību, liela mēroga ražošanu, darbu ar investoriem un globālas sociālās ietekmes iniciatīvas, radot iespējas zinātnes, klīniskā darba, inženierijas, ražošanas, komercdarbības un uzņēmuma funkcijās.
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Vakances uzņēmumā

Senior Regulatory Affairs Manager, Biomaterials

Lead regulatory strategy for Johnson & Johnson Orthopaedics’ biomaterials, biologics, and combination product programs. Oversee submissions, due diligence, and regulatory support for external innovation partnerships.

USAmerikas Savienotās ValstisMAMasačūsetsaPAPensilvānija
117 000 $ – 201 250 $ / gads
HibrīdiPilna slodzeVecākais speciālistsVadošais speciālistsNepieciešamā Valoda: angļuAtbilstība

Apraksts

  • Shape regulatory strategies for biomaterials, biologics, combination products, and externally sourced innovations.
  • Advise on regulatory considerations early in development and contribute to due diligence and business development.
  • Guide products through development, clinical programs, submissions, approvals, launch preparation, and lifecycle management.
  • Direct regulatory engagements with agencies around the world.
  • Oversee Regulatory Affairs work, set priorities, and explain objectives, risks, and recommendations.
  • Prepare and maintain BLAs, IDEs and supplements, PMAs and supplements, 510(k)s, De Novo requests, HDEs, annual reports, global change notifications, and technical documentation.
  • Set regulatory direction for pipeline programs, clinical development, and global launch readiness.
  • Collaborate with R&D, Quality, Clinical, Medical Affairs, Supply Chain, Commercial, Business Development, and other partners.
  • Use independent judgment to resolve complex regulatory matters and deliver key regulatory work.
  • Guide Regulatory Affairs colleagues and cross-functional teams through daily coaching and technical advice.
  • Create and deliver training on regulatory, CMC, CGMP, biologics, combination product, and clinical investigation requirements.
  • Coordinate communications with global and regional or local regulatory agencies.
  • Keep company policies, procedures, and practices aligned with regulatory requirements.
  • Support approval and clearance efforts, identifying capability gaps and ways to address them.
  • Lead regulatory screening and technical diligence for external innovation, partnerships, licensing, acquisitions, and business development.
  • Represent the Biomaterials External Innovation regulatory function in governance forums, partner discussions, diligence, and agency engagements.

Prasības

  • Bachelor’s degree or higher in a scientific, engineering, pharmacy, or other relevant technical field.
  • At least eight years of relevant experience in medical devices, biologics, pharmaceuticals, combination products, or another regulated healthcare industry.
  • Demonstrated experience supporting complex product development programs.
  • Specialized knowledge of Chemistry, Manufacturing, and Controls (CMC) and Current Good Manufacturing Practice (CGMP) requirements.
  • Experience creating and carrying out regulatory strategies aligned with business objectives.
  • Direct experience developing, submitting, or maintaining BLAs and IDEs is strongly preferred.
  • Experience evaluating early-stage external innovations, conducting regulatory diligence, and supporting partnerships or business development is strongly preferred.
  • Expertise in biologics, biomaterials, combination products, CMC, CGMP, BLA, and IDE requirements.
  • Strong written and verbal communication skills.
  • Ability to work effectively with cross-functional stakeholders and external partners.

Priekšrocības

  • Consolidated retirement pension plan.
  • 401(k) savings plan.
  • Long-term incentive program.
  • 120 hours of vacation per calendar year.
  • 40 hours of sick time per calendar year; 48 hours for Colorado residents and 56 hours for Washington residents.
  • 13 paid holidays per calendar year, including floating holidays.
  • Up to 40 hours of work, personal, and family time per calendar year.
  • 480 hours of parental leave within one year of a child’s birth, adoption, or foster placement.
  • Bereavement leave: 240 hours for an immediate family member or 40 hours for an extended family member per calendar year.
  • 80 hours of caregiver leave in a rolling 52-week period.
  • 32 hours of volunteer leave per calendar year.
  • 80 hours of military spouse time off per calendar year.
  • Hybrid work arrangement.

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